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INTRODUCTION: Blinding participants to randomization is a cornerstone of science. However, participant beliefs about their allocation can influence outcomes. We examined blind integrity, the association between trial arm belief and cessation, and potential mechanisms linking treatment arm and treatment arm belief among people with major depressive disorder (MDD) who smoke receiving varenicline in a placebo-controlled trial. METHODS: 175 participants were asked at the end of treatment (EOT) if they thought they received placebo, varenicline, or were not sure. We assessed the relationship between treatment arm belief and actual treatment allocation, examined the association between treatment arm belief and EOT cessation, and evaluated changes in craving, withdrawal, side effects, depression symptoms, and smoking reward as mediators through which treatment arm was believed. RESULTS: Treatment arm belief was significantly associated with actual arm assignment (χ2(2)=13.0, p=0.002). Participants in the varenicline arm were >3 times as likely to believe they were taking varenicline, vs. "not sure" (RR=3.05 [1.41-6.60], p=0.005). Participants in the placebo arm were just as likely to believe they were taking placebo vs. "not sure" (χ2[2]=0.75, p=0.69). Controlling for treatment arm, belief that one received varenicline was significantly associated with an increase in cessation rate (OR=5.91 [2.06-16.92], p=0.001). Change in the rewarding experience of smoking may mediate participant ability to discern getting varenicline B=0.077 [0.002-0.192], p <0.05). CONCLUSIONS: Participants receiving varenicline can discern that they received varenicline and this belief is associated with higher cessation rates. Research is needed to continue to examine how participants correctly identify their allocation to varenicline.

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PURPOSE: Few cancer centers systematically engage patients with evidence-based tobacco treatment despite its positive effect on quality of life and survival. Implementation strategies directed at patients, clinicians, or both may increase tobacco use treatment (TUT) within oncology. METHODS: We conducted a four-arm cluster-randomized pragmatic trial across 11 clinical sites comparing the effect of strategies informed by behavioral economics on TUT engagement during oncology encounters with cancer patients. We delivered electronic health record (EHR)-based nudges promoting TUT across four nudge conditions: patient only, clinician only, patient and clinician, or usual care. Nudges were designed to counteract cognitive biases that reduce TUT engagement. The primary outcome was TUT penetration, defined as the proportion of patients with documented TUT referral or a medication prescription in the EHR. Generalized estimating equations were used to estimate the parameters of a linear model. RESULTS: From June 2021 to July 2022, we randomly assigned 246 clinicians in 95 clusters, and collected TUT penetration data from their encounters with 2,146 eligible patients who smoke receiving oncologic care. Intent-to-treat (ITT) analysis showed that the clinician nudge led to a significant increase in TUT penetration versus usual care (35.6% v 13.5%; OR = 3.64; 95% CI, 2.52 to 5.24; P < .0001). Completer-only analysis (N = 1,795) showed similar impact (37.7% clinician nudge v 13.5% usual care; OR = 3.77; 95% CI, 2.73 to 5.19; P < .0001). Clinician type affected TUT penetration, with physicians less likely to provide TUT than advanced practice providers (ITT OR = 0.67; 95% CI, 0.51 to 0.88; P = .004). CONCLUSION: EHR nudges, informed by behavioral economics and aimed at oncology clinicians, appear to substantially increase TUT penetration. Adding patient nudges to the implementation strategy did not affect TUT penetration rates.

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BACKGROUND: Smoking contributes to significant morbidity and mortality in people with HIV. People with HIV have relatively high nicotine metabolism rates, as measured by the nicotine metabolite ratio (NMR, 3-hydroxycotinine/cotinine). A higher NMR is associated with difficulty quitting smoking. We hypothesized that HIV infection might upregulate nicotine metabolism. SETTING: A retrospective study of male current smokers in the Multicenter AIDS Cohort Study who HIV seroconverted between 1985 and 1993. METHODS: Eligibility included having plasma stored before and after confirmed HIV seroconversion and current tobacco use. Samples were selected from the closest available visits before (median 3.3 months) and after (median 9.4 months) seroconversion. Antiretroviral therapy use was exclusionary. Cotinine and 3-hydroxycotinine were measured using liquid chromatography-tandem mass spectrometry. We compared NMR from plasma pre-HIV and post-HIV infection using signed-rank tests. We targeted a sample size of 71 pairs to achieve 80% power to detect a 0.1 unit increase in NMR with P = 0.05. RESULTS: We analyzed paired samples from 78 participants; the median age was 34.5 years [interquartile range (IQR 29-40 years)]. The median NMR pre-HIV and post-HIV was 0.45 (IQR 0.32-0.54) and 0.46 (IQR 0.34-0.56), respectively. The median change in NMR postseroconversion was +0.01 (IQR -0.05, +0.09), P = 0.25. Stratification of median change in NMR by timing between samples or time since HIV seroconversion did not alter this finding. CONCLUSIONS: Acquiring HIV had no measurable effect on NMR. We postulate that upregulation of the NMR may be due to direct pharmacologic effects of HIV medications or metabolic changes in response to HIV infection.

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BACKGROUND: People with HIV (PWH) smoke tobacco at much higher rates than the general population. Previous research has shown that PWH have faster nicotine metabolism than HIV-uninfected individuals, which may underlie this disparity, but the cause is unknown. We investigated whether higher nicotine metabolite ratio (NMR; 3-hydroxycotinine:cotinine), a validated biomarker of nicotine metabolism through CYP2A6, was associated with antiretroviral use among HIV-infected smokers. METHODS: We conducted a retrospective cohort study of HIV-positive smokers in the University of Pennsylvania Center for AIDS Research cohort. We compared the NMR before viral suppression (>10,000 copies/mL) and after viral suppression on antiretroviral therapy (<200 copies/mL). We used mixed-effects linear regression to analyze the change in NMR after viral suppression and assessed for effect modification by efavirenz use. RESULTS: Eighty-nine individuals were included in the study. We observed effect modification by efavirenz use (interaction term for efavirenz use, P < 0.001). Among those on nonefavirenz regimens, the mean NMR increased by 0.14 (95% confidence interval: 0.05 to 0.23, P = 0.002). Among those on efavirenz-containing regimens, the mean NMR increased by 0.53 (95% confidence interval: 0.39-0.66, P < 0.001). CONCLUSIONS: We observed a clinically and statistically significant increase in NMR after viral suppression among smokers with HIV, which more than doubled among those on efavirenz-based regimens. Higher NMR among HIV-positive smokers on antiretroviral therapy may help explain the higher rates of tobacco use and lower quit rates among PWH in care. These findings suggest that regimen choice and other modifiable factors may be targets for future attempts to increase success rates for tobacco cessation among PWH.

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The use of antiretroviral therapy for people with HIV (PWH) has improved life expectancy. However, PWH now lose more life-years to tobacco use than to HIV infection. Unfortunately, PWH smoke at higher rates and have more difficulty maintaining abstinence than the general population, compounding their risk for chronic disease. In this Commentary, we describe a United States National Cancer Institute-led initiative to address the relative lack of research focused on developing, testing, and implementing smoking cessation interventions for PWH. This initiative supports seven clinical trials designed to systematically test and/or develop and test adaptations of evidence-based smoking cessation interventions for PWH (eg, combination of behavioral and pharmacological). We summarize each project, including setting/recruitment sites, inclusion/exclusion criteria, interventions being tested, and outcomes. This initiative provides critical opportunities for collaboration and data harmonization across projects. The knowledge gained will inform strategies to assist PWH to promote and maintain abstinence, and ensure that these efforts are adaptable and scalable, thereby addressing one of the major threats to the health of PWH. Reducing smoking behavior may be particularly important during the COVID-19 pandemic given that smokers who become infected with SARS-CoV-2 may be at risk for more severe disease. IMPLICATIONS: This Commentary describes a National Cancer Institute-led initiative to advance the science and practice of treating tobacco use among PWH, which is now responsible for more life years lost than HIV. We describe the scope of the problem, the objectives of the initiative, and a summary of the seven funded studies. Harmonization of data across projects will provide information related to treatment mediators and moderators that was not previously possible. Stakeholders interested in tobacco cessation, including researchers, clinicians and public health officials, should be aware of this initiative and the evidence-base it will generate to advance tobacco treatment among this high-risk population.

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INTRODUCTION: Pregnant women exposed chronically to opioids smoked more cigarettes per day (CPD) and had a higher nicotine metabolite ratio (NMR), 3-hydroxycotinine/cotinine, a biomarker of nicotine metabolism and clearance, than those not receiving opioids. We examined CPD and NMR in a group of pregnant smokers, a quarter of whom were receiving opioid agonist therapy (OAT). AIMS AND METHODS: Pregnant smokers recruited to participate in a placebo-controlled trial of bupropion for smoking cessation provided a blood sample for measurement of NMR. RESULTS: Half (52.4%) of the 124 women with NMR data were African American. OAT-treated women (n = 34, 27.4%; 27 receiving methadone and 7 buprenorphine) were more likely to be white (79% vs. 30%, p < .001) and to have a lower mean PHQ-9 total score (2.91 [SD = 2.83] vs. 4.83 [SD = 3.82], p = .007). OAT-treated women reported smoking more CPD (9.50 [SD = 5.26] vs. 7.20 [SD = 3.65], p = .005) and had higher NMR (0.78 [SD = 0.36] vs. 0.56 [SD = 0.25], p = .001) than the non-OAT-treated group. In a linear regression analysis adjusting for race, depression severity, and CPD, NMR was greater in the OAT group (p = .025), among whom the daily methadone-equivalent dosage correlated with NMR (Spearman's ρ = 0.49, p = .003). CONCLUSIONS: Consistent with the findings of Oncken et al. (2019), we found that OAT smokers smoked more and had higher NMR than non-OAT smokers. As higher NMR is associated with a reduced likelihood of smoking cessation, the effects on NMR of both pregnancy and OAT could contribute to a lower smoking cessation rate in pregnant smokers receiving chronic opioid therapy. IMPLICATIONS: We replicated the finding that the NMR is significantly greater among pregnant smokers receiving OAT than those not receiving this treatment for opioid use disorder. Furthermore, we found that the dosage of the OAT was significantly associated with the NMR level. These findings may contribute to a poorer response to smoking cessation treatment in pregnant women treated with OAT, particularly those receiving high-dose therapy, and raise the question of whether novel approaches are needed to treat smoking in this subgroup of pregnant smokers.

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INTRODUCTION: Individuals with serious mental illness (SMI) smoke at rates two to three times greater than the general population but are less likely to receive treatment. Increasing our understanding of correlates of smoking cessation behaviors in this group can guide intervention development. AIMS AND METHODS: Baseline data from an ongoing trial involving smokers with SMI (N = 482) were used to describe smoking cessation behaviors (ie, quit attempts, quit motivation, and smoking cessation treatment) and correlates of these behaviors (ie, demographics, attitudinal and systems-related variables). RESULTS: Forty-three percent of the sample did not report making a quit attempt in the last year, but 44% reported making one to six quit attempts; 43% and 20%, respectively, reported wanting to quit within the next 6 months or the next 30 days. Sixty-one percent used a smoking cessation medication during their quit attempt, while 13% utilized counseling. More quit attempts were associated with lower nicotine dependence and carbon monoxide and greater beliefs about the harms of smoking. Greater quit motivation was associated with lower carbon monoxide, minority race, benefits of cessation counseling, and importance of counseling within the clinic. A greater likelihood of using smoking cessation medications was associated with being female, smoking more cigarettes, and receiving smoking cessation advice. A greater likelihood of using smoking cessation counseling was associated with being male, greater academic achievement, and receiving smoking cessation advice. CONCLUSIONS: Many smokers with SMI are engaged in efforts to quit smoking. Measures of smoking cessation behavior are associated with tobacco use indicators, beliefs about smoking, race and gender, and receiving cessation advice. IMPLICATIONS: Consideration of factors related to cessation behaviors among smokers with SMI continues to be warranted, due to their high smoking rates compared to the general population. Increasing our understanding of these predictive characteristics can help promote higher engagement in evidence-based smoking cessation treatments among this subpopulation.

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INTRODUCTION: Network theories of psychopathology highlight that, rather than being indicators of a latent disorder, symptoms of disorders can causally interact with one another in a network. This study examined tobacco withdrawal from a network perspective. METHODS: Participants (n = 525, 50.67% female) completed the Minnesota Tobacco Withdrawal Scale four times (2 weeks prior to a target quit day, on the target quit day, and 4 and 8 weeks after the target quit day) over the course of 8 weeks of treatment with nicotine patch and behavioral counseling within a randomized clinical trial testing long-term nicotine patch therapy in treatment-seeking smokers. The conditional dependence among seven withdrawal symptoms was estimated at each of the four measurement occasions. Influential symptoms of withdrawal were identified using centrality indices. Changes in network structure were examined using the Network Comparison Test. RESULTS: Findings indicated many associations among the individual symptoms of withdrawal. The strongest associations that emerged were between sleep problems and restlessness, and associations among affective symptoms. Restlessness and affective symptoms emerged as the most central symptoms in the withdrawal networks. Minimal differences in the structure of the withdrawal networks emerged across time. CONCLUSIONS: The cooccurrence of withdrawal symptoms may result from interactions among symptoms of withdrawal rather than simply reflecting passive indicators of a latent disorder. Findings encourage greater consideration of individual withdrawal symptoms and their potential interactions and may be used to generate hypotheses that may be tested in future intensive longitudinal studies. IMPLICATIONS: This study provides a novel, network perspective on tobacco withdrawal. Drawing on network theories of psychopathology, we suggest that the cooccurrence of withdrawal symptoms may result from interactions among symptoms of withdrawal over time, rather than simply reflecting passive indicators of a latent disorder. Results indicating many associations among individual symptoms of withdrawal are consistent with a network perspective. Other results of interest include minimal changes in the network structure of withdrawal across four measurement occasions prior to and during treatment with nicotine patch and behavioral counseling.

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INTRODUCTION: People with mental illness are more likely to smoke and less likely to receive tobacco treatment than the general population. The Addressing Tobacco Through Organizational Change (ATTOC) approach supports organizational change to increase tobacco treatment in this population. We describe preliminary study feasibility and baseline behaviors and attitudes among clients and staff regarding tobacco treatment, and assesse correlates of treatment of smoking. METHODS: Preliminary accrual, engagement, and baseline data are reported from a cluster-randomized trial comparing ATTOC to usual care. Feasibility, thus far, was the rate of site and participant accrual and engagement (eg, participants remaining in the trial). Correlates of assessing smoking, advising cessation, and providing treatment were assessed. RESULTS: Site and participant accrual is 80% (8/10) and 86% (456/533), and engagement is 100% and 82%. "Staff asking about smoking" was reported by 63% of clients and 38% of staff; "staff advising cessation" was reported by 57% of clients and 46% of staff; staff report "assisting clients with any medication" at most 22% of the time, whereas at most 18% of clients report receiving a cessation medication; 59% of clients want tobacco treatment, but 36% of staff think that it is part of their job. "Staff assisting with medications" is related to more training, believing treating smoking is part of their job, and believing patients are concerned about smoking (ps < .05). CONCLUSIONS: This trial of training in tobacco treatment within mental health care is feasible thus far; self-reported rates of tobacco treatment are low and associated with clinician attitudes and barriers. IMPLICATIONS: Evaluation of ways to help address tobacco use treatment in community mental health care is feasible and needed, including the use of technical assistance and training guided by an organizational change approach.

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INTRODUCTION: The degree to which smokers adhere to pharmacotherapy predicts treatment success. The development of interventions to increase adherence requires identification of predictors of treatment adherence, particularly among specific clinical populations. METHODS: Using data from a 12-week open-label phase of a clinical trial of varenicline for tobacco dependence among cancer patients (N = 207), we examined: (1) the relationship between self-reported varenicline adherence and verified smoking cessation and (2) demographic and disease-related variables, and early changes in cognition, affect, withdrawal, the reinforcing effects of smoking, and medication side effects, as correlates of varenicline adherence. RESULTS: At the end of 12 weeks, 35% of the sample had quit smoking and 52% reported taking ≥80% of varenicline. Varenicline adherence was associated with cessation (p < .001): 58% of participants who were adherent had quit smoking versus 11% of those who were not. Participants who experienced early reductions in depressed mood and satisfaction from smoking and experienced an increase in the toxic effects of smoking, showed greater varenicline adherence (p < .05); the relationship between greater adherence and improved cognition, reduced craving, and reduced sleep problems and vomiting approached significance (p < .10). CONCLUSIONS: Among cancer patients treated for tobacco dependence with varenicline, adherence is associated with smoking cessation. Initial changes in depressed mood and the reinforcing effects of smoking are predictive of adherence. IMPLICATIONS: The benefits of varenicline for treating tobacco dependence among cancer patients may depend upon boosting adherence by addressing early signs of depression and reducing the reinforcing dimensions of cigarettes.

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